Dutch biotechnology company, Crucell N V’s Rabies monoclonal antibody (mAb) product has entered a phase I clinical study in India, four months after launching// a similar study in the US.
Crucell has developed a human monoclonal antibody product for the post-exposure prophylaxis of rabies, using Crucell’s MAbstract and Crucell’s PER.C6 technologies. This second phase I study is closely linked to the initial phase I study that is currently being performed in the US. Both studies are conducted under FDA authority, the Indian phase I study gained approval upon review by the Drug Controller-General of India (DCGI).
The clinical trial will be a randomized, double-blind, placebo controlled study in 44 healthy volunteers that will test the antibody product alone in a dose escalation as well as in combination with rabies vaccine. The study, funded by Crucell, will be conducted through a undisclosed clinical research organization in Mumbai, India. The main parameters under investigation will be safety, tolerability and rabies virus neutralizing activity.
“We are very pleased that would could initiate this second phase I trial, as it follows favorable interim safety and tolerability data from the initial US study. The clinical testing of the Rabies antibody cocktail in Asia is the next important step for the program, as the global burden of Rabies is mostly affecting this continent. In addition to clinical evaluation of the rabies mAb cocktail in India, we are currently exploring the conduct of clinical trials in other Asian countries, including China,” said Mr Jaap Goudsmit, Chief Scientific Officer at Crucell.
Dr Deborah Briggs, Director of the Alliance for Rabies Control opined that there is a tremendous need for additional sources of rabies immune globulins (RIG) throughout the world, especially in Asia where less than three percent of patients undergoing post-exposure prophylaxis actually receive passive immune produ
cts. She said new mAb products similar to Crucell’s product will soon be available to help to solve the shortage problem and save human lives.
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